Rueber Laboratorios S.L.
⚠️ Moderate Risk
FEI: 3003834718 • Barcelona • SPAIN
FEI Number
3003834718
Location
Barcelona
Country
SPAINAddress
Angel Guimera 53-55 08902 L Hospitalet, , Barcelona, , Spain
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2007 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 3/16/2007 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 3/16/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 3/16/2007 | 53EC07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 3/16/2007 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Rueber Laboratorios S.L.'s FDA import refusal history?
Rueber Laboratorios S.L. (FEI: 3003834718) has 5 FDA import refusal record(s) in our database, spanning from 3/16/2007 to 3/16/2007.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Rueber Laboratorios S.L.'s FEI number is 3003834718.
What types of violations has Rueber Laboratorios S.L. received?
Rueber Laboratorios S.L. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Rueber Laboratorios S.L. come from?
All FDA import refusal data for Rueber Laboratorios S.L. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.